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U.S. Department of Health and Human Services

Drugs

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Quality Systems

 

The requirements of good manufacturing practice are underpinned by a central objective: to create a system of programs, policies, processes, and facilities that prevent errors and defects. Senior managers in the drug industry are responsible for the effectiveness of this system, which is known as the Pharmaceutical Quality System (PQS). A PQS is successful when it assures an ongoing state of control. In a healthy PQS, managers establish a vigilant quality culture in which timely action is taken to prevent risks to quality. Lifecycle adaptations are made to address manufacturing weaknesses and continually improve systems. An effective process performance and product quality monitoring program provides early warning of emerging quality issues. Systemic solutions are implemented rather than ineffective shortcuts. A firm will also habitually attend to the seemingly small problems that quality experts remind us later would accumulate into costly, complex problems. An effective PQS will ultimately support stable processes, and predictable quality and supply.                  

 

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Quality Systems Inspections

FDA's routine surveillance inspections determine whether a site’s Quality System is operating in a state of control. Inspections cover multiple systems (see below compliance program). All inspections audit the overall quality assurance system to determine if it is functioning well. This aspect includes evaluating if responsible managers are notified of, and respond to, emerging quality problems, process control issues, or any new stresses on the system that may lead to defective medicines.

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Guidances

The US, EU, and Japan have adopted ICH Q10 “Pharmaceutical Quality Systems,” a guidance that creates a harmonized system based in GMPs and ISO. The PQS "assures that the desired product quality is routinely met, suitable process performance is achieved, the set of controls are appropriate, improvement opportunities are identified and evaluated, and the body of knowledge is continually expanded.” FDA also issued guidance in 2006 that provides further information on quality systems.

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Joint FDA/EMA/PDMA/PDA/ISPE Training on ICH Q10 Pharmaceutical Quality Systems

ICH Q10 Training has been conducted in 2011 and 2012 in US, Europe, and Japan. The training provides an introduction to ICH Q10 principles, terminology, and implementation approaches. Regulators from all three regions participated and discussed quality systems expectations. Industry from the three regions also participated, and provided practical case studies. Future training is also planned outside the ICH regions. See this link for agendas and presentations.

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PDA ICH Q10 Workshop: Responsibilities of Executive Management (Operations and Quality) Sept 2012

With a common goal to advance pharmaceutical quality systems (PQS), FDA and the industry are holding workshops exploring how to build an effective PQS to ensure an ongoing state of control. The first ICH Q10 workshop focused on the role of Executive Management to establish the right environment to enable daily quality assurance. Companies shared how a PQS that executes good science and effectively manages risk throughout the lifecycle will achieve sustainable compliance and consistent quality.

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